Udall, Heinrich, Luján, Lujan Grisham Call on FDA to Expedite EpiPen Alternatives

Concerned drastic price increases for EpiPen will force NM families to go without life-saving drug for allergic reactions

WASHINGTON - Today, U.S. Senators Tom Udall and Martin Heinrich and U.S. Representatives Ben Ray Luján and Michelle Lujan Grisham called on the U.S. Food and Drug Administration (FDA) to do everything possible to provide options for families struggling to afford the EpiPen Auto-Injector for the emergency treatment of a life-threatening allergic reaction, including carefully expediting the approval process for alternatives. Many people - including school children - who suffer from severe allergies use the EpiPen product to deliver a life-saving dose of epinephrine, but the price of the medication has risen exorbitantly in recent years. In a letter to FDA Commissioner Robert Califf, the lawmakers expressed their concern that steep price increases since the company Mylan purchased EpiPen in 2007 may put it out of reach for many New Mexico families and others.

"We are concerned that these drastic price increases will force some New Mexico families to make choices between affording a child's EpiPen or other household expenses. Many New Mexicans don't have the flexibility in their income to allow for such a dramatic increase in this low-production cost medication," the lawmakers wrote. "We request that the FDA utilize all available resources to build a robust pipeline of alternatives and carefully expedite the approval process of EpiPen alternatives and biosimilars. We look forward to hearing back from you about possible solutions to this issue and hearing more about steps you are taking to ensure that competitive options are carefully considered and approved for EpiPens and other needlessly high cost pharmaceuticals."

In their letter, the lawmakers indicated that the cost of EpiPens in the United States has risen from $57 each in 2007 to a reported $608 for set of two - an increase of more than 500 percent. They also noted that in some other countries, the price of EpiPens is significantly cheaper and alternatives with comparable prices are available. "In France, two EpiPens cost approximately $85 and in the United Kingdom two cost $119," they wrote. "Notably, in Canada, a Mylan brand EpiPen costs $131. In addition to the EpiPen, alternatives such as Anapen are available in France, Canada and the United Kingdom with prices comparable to the EpiPen."

The full text of the lawmakers' letter is available below and here.

Dr. Robert M. Califf
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Califf,

We are writing today out of concern over the rapidly increasing cost of basic pharmaceuticals, specifically EpiPen (epinephrine injection) Auto-Injector, which is used in emergency treatment for anaphylaxis. We are concerned that recent steep increases in price may put this common medication out of reach for people who desperately need it.

According to various news reports, Mylan purchased EpiPen in 2007. The EpiPen has been in used since 1977 and when Mylan bought it in 2007, it cost $57 each. Today, the cost of two EpiPens has risen to a reported $608 for an increase of more than 500 percent. In France, two EpiPens cost approximately $85 and in the United Kingdom two cost $119. Notably, in Canada, a Mylan brand EpiPen costs $131. In addition to the EpiPen, alternatives such as Anapen are available in France, Canada and the United Kingdom with prices comparable to the EpiPen.

We have heard from many concerned New Mexicans, including one of whom used to pay $16 for her yearly prescribed EpiPen and now with the same private insurance she is paying more than $100. We are concerned that these drastic price increases will force some New Mexico families to make choices between affording a child's EpiPen or other household expenses. Many New Mexicans don't have the flexibility in their income to allow for such a dramatic increase in this low-production cost medication.

We request that the FDA utilize all available resources to build a robust pipeline of alternatives and carefully expedite the approval process of EpiPen alternatives and biosimilars. We look forward to hearing back from you about possible solutions to this issue and hearing more about steps you are taking to ensure that competitive options are carefully considered and approved for EpiPens and other needlessly high cost pharmaceuticals.